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NCT01948908 · ClinicalTrials.gov registry record · Phase 2
Volumes of Administration for Intranasal Midazolam
A Phase 2 study, sponsored by Columbia University.
- Completed
- Registry status
- Phase 2
- Development phase
- 99
- Enrollment target
NCT01948908 is a Phase 2 study that has completed, run by Columbia University. The registered enrollment target is 99 participants.
The verdict
NCT01948908, a Phase 2 study, has completed, sponsored by Columbia University.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 99 participants
- Enrollment target
Study Summary
The purpose of this study is to determine exactly how much drug volume should be administered into each nare, so that the drug absorption can be maximized and the amount that runs out of the nose, or is swallowed, is minimized, thereby optimizing the effectiveness of any drug given intranasally. The investigators will determine this ideal "volume of administration" by studying intranasal midazolam in children who require sedation to facilitate laceration repairs. The investigators will evaluate both clinical outcomes as well as pharmacokinetic outcomes associated with each volume of administration. We will block randomize children to receive intranasal midazolam in maximum aliquots of one of the three following VOA: 200 microliters (mcL), 500 mcL, or 1000 mcL.
Interventions
- DRUG Intranasal midazolam
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 99 participants |
| Start Date | 2013-06 |
| Est. Completion | 2015-09 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01948908
The ClinicalTrials.gov registry entry for NCT01948908 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 99 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Columbia University, which has 958 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Intranasal midazolam is the first listed.
NCT01948908 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01948908 about?
NCT01948908 is a clinical study titled "Volumes of Administration for Intranasal Midazolam". The purpose of this study is to determine exactly how much drug volume should be administered into each nare, so that the drug absorption can be maximized and the amount that runs out of the nose, or is swallowed, is minimized, thereby optimizing the effectiveness of any drug given intranasally. The...
What is the current status of trial NCT01948908?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 99 participants. The study started on 2013-06. Estimated completion is 2015-09.
What interventions are being tested in trial NCT01948908?
The interventions under investigation include: Intranasal midazolam (DRUG).
Who is sponsoring clinical trial NCT01948908?
This trial is sponsored by Columbia University, which has 958 total clinical trials registered on ClinicalTrials.gov.
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